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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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FDA Approves 20th Biosimilar, 5th for Roche’s Herceptin

The US Food and Drug Administration (FDA) on Thursday approved Amgen’s Kanjinti (trastuzumab-anns), which is the fifth biosimilar to be approved for Roche’s Herceptin (trastuzumab) and 20th biosimilar overall.

Although none of the five Herceptin biosimilars have launched in the US yet, the first launches are expected soon. Roche has settled three court cases with Pfizer, Mylan and Biocon, and Celltrion and Teva. Roche also said publicly that it expects competition sometime in the second half of 2019.

Mylan said in March 2017 that it anticipates it will be the first company to launch a biosimilar to Herceptin in the US.

But none of the companies with approved Herceptin biosimilars have said specifically when a US launch will occur. Roche told Focus in a statement: "We expect biosimilar versions of our medicines to start to become available in the United States this year."

In addition to Kanjinti, competitors include Pfizer’s Trazimera (trastuzumab-qyyp), approved in March; Merck and Samsung Bioepis’ Ontruzant (trastuzumab-dttb), approved in January; Celltrion and Teva’s Herzuma (trastuzumab-pkrb), approved in December 2018; and Mylan and Biocon’s Ogivri (trastuzumab-dkst), approved in December 2017.

In Europe, according to Bernstein Research, Herceptin biosimilars are now capturing 38% share of the reference product market after 10 months of competition. There are three competitors for Herceptin in Europe: Ontruzant, which launched last March and has 12% of the market; Herzuma, which launched last May and has 18% of the market, and Amgen’s Kanjinti, which has captured 8% of the market.

Herceptin sales in 2018 totaled almost $7 billion worldwide for Roche. But Herceptin sales fell by 16% in Europe in 2018 because of the biosimilar launches, the company said.